ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13255

Study information

Scientific title

Breast activity and healthy eating after diagnosis - 2 During chemotherapy for early breast cancer

Acronym

B-AHEAD 2

Study hypothesis

Excess weight at the time of breast cancer diagnosis and weight gain during adjuvant chemotherapy increases the risk of breast cancer recurrence and death. We and others have demonstrated that continuous energy restriction (CER) and exercise is only partially effective at limiting the 2.5-3kg weight gain which occurs during chemotherapy, and for promoting weight loss for overweight women. Our other studies in non cancer patients have shown intermittent energy restriction (IER) is equivalent or superior to continuous restriction for weight control, and our pilot studies indicate that IER could be useful amongst chemotherapy patients because the days after chemotherapy administration can be avoided.

The purpose of this study is to formally assess the feasibility and effectiveness of IER to prevent chemotherapy induced weight gain and promote weight loss for overweight women compared with continuous energy restriction in a randomised trial (n=170). This study will re test whether continuous energy restriction can be effective, and whether the novel IER is better. The trial aims to identify a much needed regimen for weight control and toxicity reduction for breast cancer patients receiving chemotherapy. If either of our test regimes are succesful, this would then be tested in a larger phase III trial to evaluate its effects on relapse free and overall survival.

Overall trial start date

26/11/2012

Overall trial end date

26/03/2014

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Scheduled to have standard adjuvant or neoadjuvant chemotherapy2. Breast cancer stage I to III3. Any age >18 years: weight affects prognosis amongst preandpost menopausal women4. BMI>19 Kg / m2 (Using IER and exercise we aim to avoid weight gain in all patients; this may lead to some weightloss in normal weight individuals).5. Ability to understand written instructions and have completed baseline 7 day diet and exercise diaries.6. Resident within Greater Manchester or Cheshire area only in order to maximise uptake and retention to interventions and study.7. Written informed consent